
Precision Medicine Initiative Brings News Tasks to FDA
FDA says it is “weighing the appropriate regulatory approach” to handle the tasks outlined by President Obama’s new Precision Medicine Initiative.
President Obama recently announced in his State of the Union address that he plans to allocate $215 million in the 2016 budget for a Precision Medicine Initiative, and this money will go to the National Institutes of Health (NIH), the National Cancer Institute, the Office of the National Coordinator for Health Information Technology (ONC), and the Food and Drug Administration (FDA). Part of President Obama’s plan for a comprehensive plan includes a push to compile a national database full of genomic sequencing data.
In the White House
FDA’s effort to gather patient data privately and evaluate NGS technologies for accuracy and reliability is fodder for public discussion, Hamburg stressed, and will therefore be the topic of public meeting on Feb. 20, 2015.
Although many pharmaceutical companies may welcome the news that more data will be available to access, some also worry that the increased volume of data may not easily be digested in a usable way. Vertex’s CEO Jeffrey Leiden told
Sources:
White House
FDA Blog
Bloomberg
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